Efficacy, Immunogenicity and Safety of COVID-19 Vaccine , Inactivated in Children and Adolescents

NCT04992260 | Completed Phase 3

• 1 other identifier: PRO-nCOV-3002
• Study Type: interventional
• Target: 11,349
• Locations: 4 countries
• Sites: 38

Brief Summary

This study is a global multi-center , case-driven, randomized, double-blinded, and placebo-controlled phase Ⅲ clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the efficacy of two dose of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 6 months to 17 years.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Efficacy index-incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset

  Incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset at least 14 days after the second dose

  14 days after the second dose

Secondary Outcomes (8)

• Efficacy index-incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset

  14 days after the first dose

• Efficacy index-incidence of RT-PCR confirmed, symptomatic COVID-19 cases with onset in SARS-CoV-2 uninfected participants

  14 days after the second dose

• Efficacy index-incidence of hospitalization/severe/death caused by COVID-19 with onset

  14 days after the second dose

• Safety index-occurrence, intensity, duration, and relationship of solicited local and systemic AEs and of unsolicited AEs

  During 7 days following each dose vaccination and during 28 days post-vaccination

• Safety index-occurrence and relationship of SAEs

  From first dose to 12 months after the last dose

Study Arms (2)

Experimental Group

EXPERIMENTAL

subjects will receive two doses of inactivated COVID-19 vaccine on day 0 and day 28.

Biological: Inactivated COVID-19 Vaccine

Control Group

PLACEBO COMPARATOR

subjects will receive two doses of placebo on day 0 and day 28.

Biological: Controlled vaccine

Interventions

Inactivated COVID-19 Vaccine BIOLOGICAL

The inactivated COVID-19 vaccine was manufactured by Sinovac Research\& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection

Also known as: CoronaVac

Experimental Group

Controlled vaccine BIOLOGICAL

The placebo was manufactured by Sinovac Research\& Development Co., Ltd.The composition is aluminium hydroxide,The appearance of the placebo is consistent with the vaccine, which is a milky-white suspension.

Also known as: Placebo

Control Group

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children and adolescents aged 6 months to 17 years;
• The participants and/or their guardians are able to understand and sign the informed consent voluntarily (in accordance with the local regulations);
• Able to comply with study procedures based on the assessment of the Investigator;
• Female participants of childbearing potential (post-menarche girls or in accordance with the local standard of care) may be enrolled in the study if the participant fulfills all the following criteria:
• Has a negative pregnancy test on the day of the first dose (Day 0).
• Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 0).
• Has agreed to continue adequate contraception through 3 months following the second dose (Day 28).
• Is not currently breastfeeding.
• Must be willing to provide verifiable identification (in accordance with the local regulations), has means to be contacted and to contact the investigator during the study.

You may not qualify if:

• History of confirmed infection of SARS CoV-2 prior to randomization;
• Close contact with a confirmed COVID-19 within 14 days prior to randomization;
• Prior administration of an investigational coronavirus vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19;
• Allergy to vaccines or vaccine/placebo ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneuroedema;
• Personal or first-grade relative (siblings) history of multisystem inflammatory disease in children (MIS-C);
• Significant chronic illnesses that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion (may include, but are not limited to cardiovascular disease, liver or kidney disorders, respiratory illnesses)
• Significant chronic central nervous system diseases or neuromuscular disorders, psychosis or severe cognitive behavioral disorder, in the opinion of the investigator, including epilepsy, autism spectrum disorder, intellectual disabilities (excluding Down Syndrome);
• Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
• History of autoimmune and/or haematological diseases (including but not limited to systemic lupus erythematosus, thyroidectomy, autoimmune thyroid disease, any form of malignant tumor, asplenia, functional asplenia, or splenectomy resulting from any condition); well controlled type I diabetes mellitus is allowed;
• History of bleeding disorders (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture;
• Immunosuppressive therapy (systemic corticoid therapy, e.g. prednisone ≥2 mg/Kg/d or ≥20 mg/day for \>14 days), cytotoxic therapy (antineoplastic chemotherapy, radiation therapy), (excluding topical or aerosol corticosteroid therapy) in the past 6 months;
• Receipt of blood products or immunoglobulins in the past 3 months;
• Receipt of other investigational drugs in the past 30 days;
• Receipt of attenuated live vaccines in the past 14 days;
• Receipt of inactivated or subunit vaccines in the past 7 days;

Sponsors & Collaborators

• Sinovac Research and Development Co., Ltd.: lead

Study Sites (38)

Hospital de Puerto Montt

Port Montt, Los Lagos Region, Chile

Location

Clínica Alemana Valdivia

Valdivia, Los Ríos Region, Chile

Location

Hospital Gustavo Fricke

Viña del Mar, Región de Valparaíso, Chile

Location

Hospital Universidad Clinico de Antofagasta

Antofagasta, Santiago Metropolitan, Chile

Location

Hospital Roberto del Río

Independencia, Santiago Metropolitan, Chile

Location

Clínica San Carlos de Apoquindo

Las Condes, Santiago Metropolitan, Chile

Location

Clínica Universidad de los Andes

Las Condes, Santiago Metropolitan, Chile

Location

San Joaquín

Macul, Santiago Metropolitan, Chile

Location

Hospital Sótero del Río

Puente Alto, Santiago Metropolitan, Chile

Location

Hospital Ezequial Gonzalez

San Miguel, Santiago Metropolitan, Chile

Location

Marcoleta

Santiago, Santiago Metropolitan, Chile

Location

Clínica Alemana

Vitacura, Santiago Metropolitan, Chile

Location

Hospital Wanita dan Kanak-Kanak Sabah

Kota, Kinabalu Sabah, 88996, Malaysia

Location

Klinik Kesihatan Cheras Baru

Cheras, Kuala Lumpur, 56100, Malaysia

Location

Hospital Raja Permaisuri Bainun

Ipoh, Perak, 30450, Malaysia

Location

Hospital Seberang Jaya

Seberang Jaya, Pulau Pinang, 13700, Malaysia

Location

Hospital Miri

Miri, Sarawak, 980000, Malaysia

Location

Hospital Sibu

Sibu, Sarawak, 96000, Malaysia

Location

Hospital Pengajar UiTM Puncak Alam

Bandar, Selangor, 42300, Malaysia

Location

Klinik Kesihatan Pandamaran

Port Klang, Selangor, 42000, Malaysia

Location

Hospital Sungai Buloh

Sungai Buloh, Selangor, 47000, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Asian Hospital and Medical Center

City of Muntinlupa, Philippines

Location

National Children's Hospital

Manila, Philippines

Location

Philippine Children's Medical Center

Manila, Philippines

Location

Philippine General Hospital

Manila, Philippines

Location

University of Philippines, National Institute of Health

Manila, Philippines

Location

Mecru Clinical Research Unit

Ga-Rankuwa, Gauteng, 1818, South Africa

Location

Mecru Clinical Research Unit

Bellville, 0204, South Africa

Location

Tiervlei Trial Centre

Bellville, 7530, South Africa

Location

Worthwhile Clinical Trials

Benoni, 1501, South Africa

Location

Reimed Reicherpark

Boksburg, South Africa

Location

Newtown Clinical Research Centre

Johannesburg, 2113, South Africa

Location

Madibeng Centre for Research

Madibeng, 0250, South Africa

Location

Be Part Research

Paarl, 7626, South Africa

Location

Global Clinical Trials

Pretoria, 0083, South Africa

Location

Sandton Medical Research Centre

Sandton, 2196, South Africa

Location

Soweto Clinical Trials Center

Soweto, 1459, South Africa

Location

Related Publications (2)

• Rivera-Perez D, Mendez C, Diethelm-Varela B, Melo-Gonzalez F, Vazquez Y, Meng X, Xin Q, Fasce RA, Fernandez J, Mora J, Ramirez E, Acevedo ML, Valiente-Echeverria F, Soto-Rifo R, Grifoni A, Weiskopf D, Sette A, Astudillo P, Le Corre N, Abarca K, Perret C, Gonzalez PA, Soto JA, Bueno SM, Kalergis AM. Immune responses during COVID-19 breakthrough cases in vaccinated children and adolescents. Front Immunol. 2024 May 15;15:1372193. doi: 10.3389/fimmu.2024.1372193. eCollection 2024.

  PMID: 38812507 DERIVED

• Soto JA, Melo-Gonzalez F, Gutierrez-Vera C, Schultz BM, Berrios-Rojas RV, Rivera-Perez D, Pina-Iturbe A, Hoppe-Elsholz G, Duarte LF, Vazquez Y, Moreno-Tapia D, Rios M, Palacios PA, Garcia-Betancourt R, Santibanez A, Pacheco GA, Mendez C, Andrade CA, Silva PH, Diethelm-Varela B, Astudillo P, Calvo M, Cardenas A, Gonzalez M, Goldsack M, Gutierrez V, Potin M, Schilling A, Tapia LI, Twele L, Villena R, Grifoni A, Sette A, Weiskopf D, Fasce RA, Fernandez J, Mora J, Ramirez E, Gaete-Argel A, Acevedo ML, Valiente-Echeverria F, Soto-Rifo R, Retamal-Diaz A, Munoz-Jofre N; PedCoronaVac03CL Study Group,; Meng X, Xin Q, Alarcon-Bustamante E, Gonzalez-Aramundiz JV, Le Corre N, Alvarez-Figueroa MJ, Gonzalez PA, Abarca K, Perret C, Carreno LJ, Bueno SM, Kalergis AM. Inactivated Vaccine-Induced SARS-CoV-2 Variant-Specific Immunity in Children. mBio. 2022 Dec 20;13(6):e0131122. doi: 10.1128/mbio.01311-22. Epub 2022 Nov 16.

  PMID: 36383021 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zeng Gang, Doctor

  Facultad de Medicina, Pontlficla Universidad Católica de Chile

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 5, 2021
• Study Start: September 10, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

CL (12); PH (5); ZA (11); MY (10)